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Completed

NCT Number: NCT00116142

Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer

This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

30 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Dana-Farber Cancer Institute and (Sanofi-Aventis Consortium)

Boston, Massachusetts, 02115, United States

About this study

Radiation therapy plus six months of hormone therapy is one standard way of treating men with high-risk prostate cancer. In this study, we want to see whether or not adding the chemotherapy drug docetaxel (Taxotere)will make this treatment more effective. Docetaxel has shown a benefit in median survival when given to men who have become resistant to hormonal therapy and in men who have metastatic prostate cancer (spread to other areas of the body).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy proven prostate cancer
  • Clinical Tumor Category T1b, T1c, T2a and PSA greater than (>) 10 or Gleason score equal or greater than 4+3=7 or PSA velocity > 2.0 ng/ml per year and also eligible patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal Vesicle Invasion); Gleason = or > 3+4=7 with 50% or more cores positive
  • Negative bone scan
  • Lymph node assessment by CT or MR
  • Adequate hematologic function (Blood Counts)
  • Adequate liver functions (blood tests)
  • ECOG performance Status 0 or 1
  • Peripheral neuropathy must be =< grade 1
  • PSA obtained within 3 months of entry

Exclusion criteria

  • Prior history of malignancy that are < 5 years except for cancers found to be "in-situ" and would not likely impact a patient's life expectancy with appropriate medical management.
  • Prior pelvic radiation therapy
  • Prior hormonal therapy (up to 4 weeks prior to enrollment allowed)
  • Individuals unable to tolerate lying still 5 - 10 minutes
  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 90.

Treatment and study plan

docetaxel

Drug

60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.

Other names: Taxotere

Androgen Hormonal Suppression and Radiation

Drug

Total Androgen Ablation and external beam radiation therapy

Androgen Suppression Therapy and Radiation Therapy

Drug

Total Androgen Ablation and External Beam Radiation Therapy

Primary outcomes

  1. 10-Year Restricted Mean Survival Time for Overall Survival

    Time frame: Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.

    Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up

Secondary outcomes

  1. 10-year Biochemical Recurrence (PSA Failure)

    Time frame: PSA was measured following the end of RT, then every 6 months for 5 years and annually thereafter, 10 years

    Time to biochemical recurrence was defined as the time from date of random assignment to the earliest of PSA failure or initiation of salvage therapy, or censored at the date of last disease assessment for those without PSA failure. PSA failure was defined according to the 2006 RTOG-ASTRO Phoenix definition (i.e., A PSA rise by 2 ng/mL or more above the nadir).

    10-year biochemical recurrence rate was estimated from a competing risk model where non-prostate cancer death was counted as competing risk.

  2. 10-year Prostate Cancer Mortality

    Time frame: Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.

    Measured from the date of random assignment to date of death from prostate cancer, or censored at the date of last follow-up in surviving patients. Patients who died due to other reasons were counted as competing risk in a competing risk model.

  3. Number of Participants With Acute Adverse Events

    Time frame: During study treatment or within 30 days of the last dose of study, up to 7.2 months from randomization

    Adverse acute events were reported via the clinical database only for toxicities considered reportable via the SAE mechanism (those of grade 2 and grade 3 events that are unexpected and possibly, probably, or definitely related/associated with treatment; or all grade 4 and grade 5 events). Common Toxicity Criteria Volume 3.0 (CTCAE) is used for this study.

  4. Number of Participants With Late Adverse Events, Any Grade and Attribution

    Time frame: Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization

    Late adverse events will be focused on GU/GI including Urinary/Fecal Incontinence, Hematuria, Diarrhea, Rectal Bleeding and other.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Sanofi

Registry information

Official study title

Docetaxel Plus 6-month Androgen Suppression and Radiation Therapy Versus 6-month Androgen Suppression and Radiation Therapy for Patients With High Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial

Important dates

Study start
2005
Primary completion
2020
Study completion
2020
First posted
Jun 28, 2005
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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